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A heroin user prepares to shoot up on the street in a South Bronx neighborhood in New York City. One... [+] reason people don't stop using illegal opioid drugs such as heroin or prescripton opioid painkillers for non-medical reasons is the fear of withdrawal symptoms. (Photo by Spencer Platt/Getty Images)

The Food and Drug Administration this week authorized an Indianapolis company to market the first device to help reduce opioid withdrawal symptoms, even though it has never been tested in a randomized controlled trial, considered the standard for demonstrating the safety and effectiveness of medical treatments.

The NSS-2 Bridge, which looks like a large hearing aid, is attached behind the ear with double-sided tape. It contains a battery-powered chip that emits electrical impulses to stimulate branches of certain nerves that link the brain with other parts of the body, according to an FDA press release. Three electrodes connected to the device by wires are placed on and near the ear.

“The only way that you can determine the extent by which this device has potential clinical effects is by doing a randomized controlled trial,” Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, told me.

In such a trial, patients would be randomly assigned to receive either the actual device or a sham device that looked like it but didn’t do anything.

Comparing the actual device to a sham device is the only way to tell for sure whether it's effective. Without that comparison, you can’t be certain whether the results seen in patients are due to the device or to the placebo effect or natural course of opioid withdrawal symptoms, which eventually dissipate on their own.

This is the NSS-2 Bridge, the first device authorized by the FDA to treat opioid withdrawal... [+] symptoms.

(Photo: Innovative Health Solutions)

But, Volkow noted, the FDA sets the bar lower for devices than it does for medicines--especially devices classified as low to moderate risk, as this one is--a fact that people with opioid use disorders and their worried loved ones are likely to overlook.

Withdrawal symptoms have been likened to those of a severe case of the flu, including nausea, vomiting, sweating, joint pain, insomnia and tremor. "The whole fear of withdrawal actually makes people take drugs," Volkow said.

That is why the NSS-2 Bridge device could prove to be very popular, despite the dearth of evidence that it works. “Because people are desperate, they’re willing to believe anything that anyone promises,” Volkow said. But the manufacturer “may be generating expectations that are not fulfilled.”

The Bridge, cleared by the FDA in 2014 for use in acupuncture, was adopted by opioid use disorder treatment programs and physicians even before the single, small study of its effectiveness in treating withdrawal symptoms was published in a peer-reviewed journal this past March.

“If you Google the Bridge device, you’ll see hundreds of stories” of people who have used it for opioid withdrawal, said Brian Carrico, president of Innovative Health Solutions (IHS), the company that markets it. Since the Bridge came on the market three years ago, Carrico told me, his company has sold about 20,000 devices. Because it works for only five days, some people who've used it for acupuncture have purchased three or four, he said.

Why bother seeking authorization to market the Bridge for relieving opioid withdrawal symptoms if treatment programs and physicians already were using it for that purpose? With an FDA-authorized medical use, Carrico’s company might have better luck persuading private insurers or government programs such as Medicaid to cover it.

Up until now, Carrico said, "it was being sold as a cash device. End of story."

Carrico said his company sold the Bridge for about $600, but I found at least one drug treatment program that has been charging $1,500 to provide it.

Of course, not everyone trying to get off opioids can afford to pay $600 or more out-of-pocket for the Bridge, so insurance coverage could greatly expand its market. A Knoxville, Tenn., television station reported Thursday that Carrico planned to meet with Tennessee Medicaid officials to discuss coverage of the Bridge.

Carrico told me he expected the device will be covered by insurance--he didn't specify what kind of insurance--in several states by Jan. 1.

It's possible that small insurance companies in a few states might decide to cover the Bridge for some patients by Jan. 1, but it's "very unrealistic and unlikely" that any state legislature would mandate coverage that soon, if at all, Cauchi told me. "State legislatures and states in general have become very cautious and very calculating before they adopt any new mandates: What exactly will the cost be, and will this raise premiums generally?"

Meanwhile, a Utah sheriff plans to provide the Bridge to county jail inmates who want to stop using opioids and commit to treatment of their opioid use disorder with medication after their release.

Enthusiasm for the Bridge--as well as the FDA's authorization to market it to treat opioid withdrawal symptoms--is based on a pilot study of 73 patients, all of whom received the device as part of their treatment for opioid use disorder.

To test the Bridge’s effectiveness, researchers administered a questionnaire called the Clinical Opiate Withdrawal Scale, or COWS, to assess patients' symptoms. The 11-item scale covers such symptoms as heart rate, pupil size, gastrointestinal upset, joint aches and runny nose or watery eyes. The higher the score, the worse the symptoms.

The researchers recorded patients' COWS scores before the Bridge device was attached to their scalp and then 20, 30 and 60 minutes afterward. Before the device was attached, the average COWS score was 20.1, the study found. Twenty minutes after Bridge was placed, the average score dropped to 7.5. At 30 minutes, it was 4.0, and at 60 minutes it was 3.1.

The researchers also recorded the COWS scores of some of the patients five days after the Bridge was placed behind their ear. In that group, the COWS score was 0.6 on day five, although, NIDA's Volkow said, by that point their scores likely would have dropped that low even if they hadn't used the device, because withdrawal symptoms usually don't last beyond five days.

In addition, 64 of the 73 study participants returned to the clinic to receive their first dose of maintenance medication (methadone or buprenorphine), which the researchers counted as a successful transition to medication-assisted treatment.

The study didn't provide answers for a variety of "fundamental questions" about the device, including the optimal intensity and duration of the electrical pulses and the best place to affix the device on the body, Volkow said.

She didn't dismiss the possibility that electrical stimulation of nerves that connect the brain to other parts of the body might work to relieve withdrawal symptoms.

"We have been trying to get researchers into this space," Volkow said. She noted that the NIH's Common Fund, which supports biomedical research programs that are beyond the scope of any single NIH institute or center, has evaluated this type of nerve stimulation for other conditions, such as epilepsy seizures.

Carrico said his company plans to do more research into the Bridge for treating opioid withdrawal symptoms, but, Volkow said, IHS has little incentive to do so, since its device now has an FDA-authorized use.

"We do not want to perpetuate treatment for which there is not evidence," she said. "It hurts me, because these people (who use the Bridge to treat withdrawal symptoms) are desperate. They have a very, very serious disease."